Food Allergies and the Pharmacy


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Are you pregnant with an allergic child?

Normally, I try to give advice that combines the benefits of my education, work experience, and living with food allergies, but today I want to talk about a frustration I have with a gap in medical knowledge and what appears to be a gap in medical research.

I recently read about a study conducted at the Murdoch Children’s Research Institute in Victoria, Australia. The study’s preliminary findings indicate that children may develop allergies in utero.

As I have written in other posts and the “about me” section of this blog, my son, E, is severely allergic to eggs, soy, peanuts, and four kinds of tree nuts. During my pregnancy with him, I was sick. Very sick. One month I lost between 15 and 20 lbs due to vomiting. TMI, I know, but this severity coupled with 1. my mother’s account of becoming extremely sick every time she drank milk while pregnant with my milk-allergic sister 2. similar social media anecdotes and 3. E’s subsequent food allergy diagnoses lead me to a question: Was the reason I was so sick while pregnant with E because I was eating food to which he was already allergic?

Several years ago, while pregnant with A, my second child, I tried to convince the OB/GYN to write a script for allergy testing–just a simple blood sample, nothing that would jeopardize the pregnancy or cause an allergic reaction on or in my body. I wondered if my sample would test positive while pregnant with an allergic child whereas normally I am not allergic. Of course I wouldn’t know if this child would be allergic until later and I would need another blood test to compare; I would also need a food-reaction journal among other things. Regardless, I wanted to test my theory. I don’t think the doctor understood what I was trying to do exactly (or maybe he thought I was crazy). He repeatedly told me that I needed to wait to test for “my” allergies until after the pregnancy. In the end, I did not have the allergy testing and, so far, A is not allergic although she does have some skin issues. I was still very sick while pregnant with A but nothing like the extremes of E’s pregnancy. So my questions remain. The article reignited my thoughts on the subject.

The study is investigating whether the allergy development is due to maternal influence (weight, diet, smoking, etc) on predisposed genes. Certainly, this aspect bears much investigation.

But, what if the genetics of the child (i.e the allergy within the baby) influence the eating habits, activity, weight (obviously not smoking) of the mother during pregnancy? In these cases, could maternal eating habits and diets be the result of the “allergic” pregnancy as opposed to the allergy being the result of the maternal diet? Perhaps it’s both; a predisposed genetic mechanism catalyzed by a diet that then becomes unsustainable due to the developed allergy of the unborn child.

To be clear, I am not talking about the typical cravings, food aversions, and nausea/vomiting of pregnancy; I am talking about extreme and/or specific cases.

To further extrapolate: Could my theory, if proven correct, lead to earlier childhood diagnosis and anaphylaxis prevention by utilizing a simple prenatal maternal allergy screening process?

This very question is the crux of my theory. If a simple blood test could prescreen for significant allergic reaction then the children could be saved the months and years of itchy rashes, breathing problems, misdiagnoses, and unnecessary medications. The mothers could avoid offending foods while pregnant and breastfeeding, thus potentially eliminating signs and symptoms in both themselves and their child. Avoidance and prevention of anaphylaxis in this population would be amazing.

Of course all this is just a theory (not even a scientifically based theory) of mine established on anecdotes of pregnancy illness vs food allergies discovered early in a child’s life, including my own. This theory also does not address those that develop allergies later in life. I would love to test my theory informally via a large-scale questionnaire or poll. Maybe I will one day, but for now: What have been your experiences while pregnant with your allergic child? Were there any noticeable differences between allergic and non-allergic sibling pregnancies?

 

Update 6/12/2015:

Could passive transfer of allergies such as with the Canadian transfusion patient account for the maternal reactions I discussed in the blog?  The case was published in the Canadian Medical Association Journal on April 7, 2015.

 

 

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Short Dated Epinephrine

Homa Woodrum, over at her blog ohmadeeness,  recently posted that numerous people are receiving short dated Epipen® and Auvi-Q®. Short dating refers to an expiration date that will expire relatively soon. Getting a short dated medication is not always a negative experience since most medications will be consumed or otherwise used within 30 to 90 days. However, as needed, or PRN medications, should not be dispensed if short dated unless absolutely necessary such as in the event of a long-term manufacturer back order, emergency event, or if the patient absolutely needs the product immediately and cannot wait for an order to be placed. PRN medications include epinephrine, albuterol rescue inhalers, nitroglycerin, and others

Homa’s post addresses the issue of what to do if you have already purchased the short dated epinephrine. Her post also provides manufacturer numbers to obtain reimbursement. I have also provided contact numbers for each manufacturer in my Epinephrine Auto-Injector Comparison Chart.  But better than dealing with the aftermath is avoiding purchasing a short dated epinephrine; I am going to outline strategies for you and the pharmacy on keeping short dated Epinephrine Auto-Injectors (EAIs) out of your hands at all.

How can a patient/parent handle a short dated EAI situation?

Try to remember to check the expiration date before leaving the pharmacy, preferably before you pay for the medication. Simply do not purchase the product unless absolutely necessary.

There are a few options in this instance:

1. Review at Drop-Off. One way to avoid short dated product is by having the pharmacy staff check the expiration date when the prescription is dropped off. This helps you avoid an unnecessary wait (if the expiration date is not acceptable) and it helps the pharmacy not fill medication that won’t be picked up. Win-Win. Plus, if the pharmacy is not crazy busy, the pharmacy staff may call other pharmacies to check on stock and expiration dates for you. Calling another pharmacy is not part of the pharmacy staff’s job, per se, but we do provide this service often, especially when asked nicely.

2. Call ahead. (I highly recommend this.) Call the pharmacy and ask them to review the expiration dates of the on-hand product. If the date is not satisfactory, do not take the prescription to that pharmacy. If your primary pharmacy does not have the product or a product with at least a year good dating, then call other local pharmacies to check their stock. Hopping from pharmacy to pharmacy in general is a bad idea, especially for people with food allergies or patients on multiple medications, but this would be one instance where it would be okay to use a pharmacy other than your home pharmacy.

3. Have the pharmacy order another box. Typically, retail pharmacies can order a product to be delivered overnight Sunday-Thursday (the orders are delivered Monday through Friday for most pharmacies). If the situation arises over a weekend or holiday, you may have to wait until the next business day for the pharmacy’s supplier. Pharmacy suppliers such as Cardinal Health and McKesson have different hours and holidays than the pharmacy; your pharmacy may be open but the supplier may not.

What if the pharmacist says she has no control over the expiration date of the medication delivered?

This statement is true. Pharmacists cannot request (or demand) specific expiration dates. However, the pharmacist can return a short dated product immediately upon delivery; I have had experience doing this with Cardinal Health. Another package can be ordered, but again, the pharmacist will not know the expiration date before it arrives.

Why would the pharmacist even fill a short dated EAI?

Pharmacies pull outdated medication frequently. Some pharmacies pull on a monthly basis, pulling all the medications that will expire the next month (i.e. anything that will expire in August is removed by the end of July), other pharmacies pull three months at a time. Additionally, technicians should be screening expiration dates at the filling/counting stage. Pharmacies have built-in redundancy, another layer of safety; this is one example. For that reason, the pharmacist may not look at the expiration date as the medication is being verified.

Overall, I believe this is a training issue. Pharmacists know that patients should be using EAIs infrequently (hopefully) and, based on that knowledge, pharmacists know that EAIs should have long expiration dates. What pharmacists may not know is that they can return a short dated product delivered by a supplier.

It’s my opinion that pharmacists should always check the expiration date on EAI at the verification stage. If the product has less than one year good dating the patient should be contacted to see how the staff should proceed.

Pharmacy Solutions

In the pharmacy, several actions can take place to prevent short dated EAIs from being dispensed.

1. Patient profile note. The pharmacy staff can add a note into the patient’s profile stating that EAIs must have one year good dating. Most retail pharmacies have some mechanism for adding patient notes and patient requests into the system.

2. Signage. (Old school but potentially very effective.)The pharmacy staff could place a sign near the shelf location of the epinephrine reminding staff to review expiration dates and return any product that is received short dated. Short dated product that cannot be returned could be stickered, or otherwise tagged, in order to alert staff of the potential problem.

3. Training. The pharmacy can focus on training by reinforcing examination of EAI expiration dates at the various stages of the filling process: when pulled from shelf, when filled by the technician, and finally when verified by the pharmacist.

4. Technology. At this point, I would settle for a prompt at the verification stage reminding the pharmacist to review the expiration date, making sure it was at least one year from the dispensing date. A hard stop mechanism requiring the manual addition of the expiration date could be another solution.

There is pharmacy technology already utilized that scans and processes the UPC codes located on each manufacturer bottle/box. The scanning process verifies that the correct medication has been selected. Ultimately, I would love to see the expiration dates and lot numbers automatically logged via the UPC scan. The data collected would help screen expiration dates but also it would aid the pharmacist in the event of mass recalls (which happen quite frequently at varying levels of severity).

Of course, number four is the most difficult action in that it would require the IT department of a corporation to become involved.

 

 


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Epinephrine Auto-Injector Comparison Chart 8/3/2014

Sorry for the late post. I was having trouble adding my comparison chart to the site. This was the best solution my sister and husband (aka my personal Geek Squad) could find; I was no help at all.

Having multiple epinephrine auto-injectors (EAI) choices available is a wonderful thing for the patient/individual; not so much for the teacher or school nurse but I will discuss that in an upcoming post. EAI selection is a personal choice based on a number of factors: price, feel, perceived ease of use, size, etc. These preferences may change or evolve with time just as our lives change.


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Pharmacy Basics: DAW codes

DAW icon

I am finishing up a week of vacation but I didn’t want to miss a week on the blog. Plus, a little alone time was much needed.

We have established that the Orange Book is a fun read, but you can bypass it by using DAW codes. DAW or Dispense as Written codes are codes that specify that a particular brand or manufacturer must be dispensed without substitutions.

There are two DAW codes that I believe are most important for our food allergy discussions/issues: DAW 1 and DAW 2.

DAW 1

DAW 1 means that the prescriber has specified that the BRAND medication only (not the “A” rated, therapeutically equivalent, generic) must be dispensed. Laws vary from state to state but, in general, the prescriber must write DAW or Dispense as Written or Brand Medically Necessary or Brand Necessary on the prescription. At this point the pharmacy is ONLY allowed to dispense that particular product, no substitutions permitted.

This can be good and bad.

The bad:

If the brand product or a specific manufacturer is not covered on your insurance, the pharmacist cannot legally switch to the generic. The pharmacist must call the prescriber and get permission to give the generic product. This will take time. The pharmacy staff may have to leave a message and, depending on how busy the prescriber’s office is, may not receive a return call for several hours to several days.

The specific medication desired may require a Prior Authorization. A Prior Authorization is when the prescriber must call the insurance company, explain why the patient must have a certain medication, and often give diagnoses.This usually happens due to cost issues. Sometimes, the insurance company wants a patient to have tried several cheaper options before allowing a more expensive medication to be covered.

For example: Brand Singulair may require a Prior Authorization since a less expensive, “A”rated generic called montelukast is available.

The good:

Some insurances will assign different copays based on DAW 1 vs DAW 2; DAW 1 being cheaper. Additionally, in instances such as with epinephrine auto-injectors, a “B” rated auto-injector cannot be substituted as with the special circumstances discussed at the end of The Orange Book post.

Example: Adrenaclick written as Brand Medically Necessary CANNOT be substituted with Lineage’s epinephrine auto-injector under any circumstance of which I am aware without the prescriber removing the DAW 1 indication.

Another way that DAW 1 can be awesome in the food allergy world is by specifying a particular manufacturer.

As we have discussed in Pharmacy Basics: NDC numbers and Package Inserts, inactive ingredients often contain food items. If you have found a manufacturer that makes a product without your particular food allergens, stick with it.

medically necessary

As always, review the package insert before purchasing the medication.  Inactive ingredients change just like the recipes for the food we eat. We must review the inactive ingredients each time the medication is picked up.

DAW 2

DAW 2 is simply the patient, patient’s guardian, or patient’s representative requesting a specific brand or manufacturer of medication.

This still may require a Prior Authorization, it may not be covered at all depending on your insurance formulary, and it will not be a less expensive copay but it may be the same copay as prescriptions specified as  DAW 1.

However, with DAW 2, if one of those problems arise, you can decide that it’s not worth the copay price or the wait that may be required for a Prior Authorization to be processed.You can say “Never mind, give me the generic.” No need to call the prescriber.

At that point, you can have the pharmacist help you find another compatible manufacturer, if one exists. This will take time, please be patient. If the pharmacist cannot find a suitable alternative, she may need to call the prescriber to see if a medication change is appropriate.

Plus, you may request the brand medication or a particular manufacturer at any time, even if it’s the third refill.

Once the pharmacy staff processes the medication, they should be able to tell you how much it costs, if it requires a “Prior Auth” (as we call it), or if it is just simply not covered.

For more information on DAW codes go here:  http://www.pharmacy-tech-resources.com/Dispense-As-Written-Codes.html

In the next few weeks, I will be posting an epinephrine auto-injector comparison chart and Pharmacy Basics: Vocabulary. Please comment below on any particular phrases or vocabulary you would like explained.

Don’t worry, there won’t be a quiz at the end.


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Pharmacy Basics: The Orange Book

No, this is not the next book on your toddler’s reading list. It’s something much more fun. And by fun, I mean completely boring, but really useful in the pharmacy world.

What is the Orange Book?

The Orange Book is a list of the drug products the FDA has approved as being equivalent to one another. The Orange Book approvals are based on safety, effectiveness, and “therapeutic equivalence”.

The FDA has added an online Orange Book search to its data base which can be accessed at:http://www.accessdata.fda.gov/scripts/cder/ob/

 Why am I telling you about this?

Recently I’ve seen several comments on social media sites with anecdotes about pharmacies substituting an Epi Pen for other epinephrine injectors. However, these items are not considered therapeutic equivalents. The Orange Book is the pharmacists guide to therapeutic equivalence, but it is also available to you as another tool in being proactive about your health, or the health of the person you are caring for.

What is therapeutic equivalence?

Therapeutic equivalence is another way of saying that the medications contain the same active ingredient; they are the same strength, the same dosage form (tablet, capsule, etc.), and that they are administered the same way (by mouth, injection, etc.)

Medications that are considered “therapeutic equivalent” can vary in color, shape, markings, and inactive ingredients (preservatives, sweeteners, dyes, flavor additives, fillers, and so on).

The inactive ingredients are of extreme importance with regards to food allergies.

What is a TE code in the Orange Book?  

These are the codes that tell you if a product is therapeutically equivalent (TE).

An “A” code (codes beginning with the letter “A”)  such as AB, AT, AO, AN are considered therapeutically equivalent.

A “B” code (codes beginning with the letter “B”) such as BX, BN, BC are, at this time, NOT considered to be therapeutically equivalent.

Why does this matter?

Pharmacists should not substitute products (without physician approval) that are not “A” rated.

A quick search of epinephrine in the Orange Book lists several products including EpiPen, Auvi-Q, and Adrenaclick. The TE code reveals a BX rating. That means that there are no approved drug products equivalent to those specific medications.

An EpiPen prescription cannot be filled with Auvi-Q and vice versa.

The Orange Book can be confusing because there is a TON of information in it to digest. You probably won’t use this often but it’s a super handy tool to have.

Now I suggest you read something a little more fun and a lot more racy: the phone book.

 

 

Note: Some states allow a pharmacist to substitute products despite a BX rating provided that certain criteria are met. Make sure, before you leave the pharmacy counter, that you have the medication you have discussed with your physician.  Ask if it is an “A” rated substitution.

 

 

 

 

 

 


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Pharmacy Basics: NDC numbers and Package Inserts

Pharmacy Basics will be a reoccurring segment about, what else, Pharmacy Basics. This post is very long but very important, please read it all. You may get bored. Feel free to pause in the middle to watch your favorite sitcom or look at pictures of cute kittens, but come back because the information is worth it.

First up, what your pharmacist needs to know.

Tell the pharmacist and pharmacy techs about any food allergies. It has been my experience that people automatically assume medication allergies but rarely divulge food allergies when asked about allergies.

Even if the pharmacy staff doesn’t specifically ask you about food allergies, you tell them. Also tell them that you are aware that certain medications contain food allergens and they are NOT usually caught by the interaction system.  We’ll talk about that in an upcoming post.

What’s an NDC number?

An NDC is the 11 digit number found on each bottle of prescription (and some over-the-counter OTC medications) that specifies the exact medication you have received.

Why does it matter?

Each manufacturer may have different inactive ingredients (which may include food allergens) as compared to other manufacturers of the same medication. For example, Drisdol, a brand name Vitamin D Supplement, contains soybean oil, while certain manufacturers of it’s generic do not.

How does an NDC number work?

An NDC is broken into three sections. The first 5 numbers represent the actual manufacturer. The middle four numbers represent the medication name and strength. The final two numbers represent the package size.

levothyroxine bottle

How do you know which NDC you have received?

Ask the pharmacist! The number may not be listed on the label provided by the pharmacy. However, the NDC dispensed is kept on record in the pharmacy’s computer system.

How will this help me?

Now that you know the NDC number, ask for the package insert. Make sure that the pharmacist understands that the package insert must be for the same NDC that you received–the actual medication that is in your bottle. NO SUBSTITUTIONS.

The package insert is the information packet that comes with the medication. It contains prescribing information, adverse reactions (aka side effects) and lots of other data about the medication.

How do I use the Package Insert?

There are two sections in the package insert that I believe are important for food allergies:

1. Warnings/Contraindications

2. Inactive ingredients (possibly found under “Description”)

levo package insert

The warnings/contraindications sections will sometimes specifically state avoidance if the patient is allergic to a particular food. BUT NOT ALWAYS! Read the inactive ingredients. Highly refined soybean oil, for example, is exempt from the FALCPA, The Food Allergen Labeling & Consumer Protection Act. Soy is one example of a food allergen that is commonly found in gel capsules.

Keep in mind that if the pharmacy needs to “partial fill” or “owe” you medication because they did not have enough in stock, this process should be repeated.

Just like food recipes change, ingredient lists change. Get in the habit of checking the package inserts, better yet ask the pharmacy staff to add a note to your profile requesting that a package insert be included with each fill (if available). If not available then the pharmacist can usually look this information up in one of his/her on-line sources.  This will take time. BE PATIENT! Third option is to call the manufacturer; the pharmacist can provide this number.

The pharmacy staff will be more than happy to help keep you and/or your child safe. That’s what we do! TRUST ME: Pharmacists and techs will go out their way to help a customer that is patient and friendly.